Clinical trials: Suture
Instability, Joint
Safety and Performance of the SUTUREFIX ULTRA and SUTUREFIX CURVED Suture Anchors in Shoulder and Hip Arthroscopic Repair
The scientific justification is to fulfill post-market clinical requirements in order to support re-certification of the CE-Mark for this marketed product and to look into safety and efficacy.
- Trial name
- NCT03691298
- Testing
- SUTUREFIX ULTRA Suture Anchor and SUTUREFIX CURVED Suture Anchor
- Where
- 9 sites in United States, Denmark and 4 more
- Volunteers
- 83 people
- Sponsor
- Smith & Nephew Orthopaedics AG
Vascular Diseases
First In-human Use of SETALUM™ Sealant: The BlueSeal Clinical Study
This is a prospective, multicenter, single-arm trial to evaluate the safety and performance of SETALUM™ Sealant in sealing suture lines at the anastomosis between native vessels and synthetic ePTFE vascular patch used during open…
- Trial name
- NCT03374735
- Testing
- SETALUM™ Sealant
- Volunteers
- 22 people
- Sponsor
- Gecko Biomedical
Eye Diseases
Dafilon® Suture Material in Patients Undergoing Ophthalmic Surgery
This is an observational, retrospective postmarket clinical follow-up study and includes all patients who underwent any ophthalmic surgery using Dafilon® suture in the selected centres between 2018 and 2020, therefore no sample…
- Trial name
- OPHTHADA (NCT05968443)
- Testing
- ophthalmic surgery
- Where
- Malaysia
- Volunteers
- 200 people
- Sponsor
- Aesculap AG
Macromastia
Study of Prineo (Dermabond Protape) Versus Sutures in Breast Procedures
This is a prospective, controlled, randomized, multi-center clinical study of up to 80 patients with full thickness surgical incisions associated with bi-lateral breast procedures.
- Trial name
- NCT00558246
- Testing
- Dermabond Protape (Prineo), Suture
- Where
- 5 sites in Belgium, Germany and 2 more
- Volunteers
- 79 people
- Sponsor
- Ethicon, Inc.
Patent Foramen Ovale (PFO)
Safety and Efficacy of the Patent Foramen Ovale Suture System for the Closure of Patent Foramen Ovale
A prospective, multicenter, randomized controlled, non-inferiority clinical trial to evaluate the efficacy and safety of the patent foramen ovale suture system in the closure treatment of patent foramen ovale.
- Trial name
- NCT07726927
- Testing
- Patent Foramen Ovale Suture System, Amplatzer PFO Occluder
- Volunteers
- 244 people
- Sponsor
- Shenzhen Bihe Medical Co., Ltd
Wounds and Injuries
ZipLine Incision Approximation Verses Suture:ZIPS3 Physician Preference Study
Zipline incision approximation vs. Suture -- zips 3 study. A prospective, multi-site, non-blinded, randomized controlled, study designed to evaluate user preferences associated with use of the zipline 3 system versus conventional…
- Trial name
- ZIPS3 (NCT03201536)
- Testing
- conventional Suture, Zip3
- Where
- 3 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- ZipLine Medical Inc.
Obesity
Incisionless Treatment for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass
It is estimated that up to 20% of patients who have Roux-en-Y Gastric Bypass (RYGB) surgery will not meet their weight loss goal, or may even regain some of the weight they initially lost.
- Trial name
- NCT00394212
- Testing
- Transoral Suturing
- Where
- 10 sites in United States
- Volunteers
- 77 people
- Sponsor
- C. R. Bard
Meniscal Tears
Evaluation on Safety and Effectiveness of the An All-inside, All-suture Meniscal Repair Device
This study is a prospective, multi-center, randomized controlled pre-market clinical trial in China to evaluate the safety and efficacy of the JuggerStitch™ Meniscal Repair Device for arthroscopic meniscal repair.
- Trial name
- NCT06899659
- Testing
- JuggerStitch™ Meniscal Repair Device, Fast-Fix 360 Meniscal Repair System
- Where
- 2 sites in China
- Volunteers
- 94 people
- Sponsor
- Zimmer Biomet
Breast Ptosis, Obesity
Evaluation of Dermal Closure With an Absorbable Barbed Suture as Compared to a Conventional Absorbable Suture
The objective of this study is to evaluate the use of an absorbable barbed suture as compared to a conventional absorbable suture when used for dermal closure during certain body contouring procedures.
- Trial name
- NCT00959374
- Testing
- V-Loc 180/90 Wound Closure Device, 3-0 Monocryl Absorbable Sutures
- Where
- 8 sites in United States, Germany
- Volunteers
- 229 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Percutaneous Closure of Arteriotomy in Common Femoral Artery
Clinical Study of the Medeon Biodesign XPro™
To access the safety and performance of the XPro System to facilitate hemostasis in patients undergoing percutaneous endovascular procedures utilizing 8-18 Fr introducer sheath via the common femoral.
- Trial name
- NCT03171155
- Testing
- XPro System
- Where
- 6 sites in Australia, New Zealand and 1 more
- Volunteers
- 28 people
- Sponsor
- Medeon Biodesign, Inc.
Breast Cancer
Coated VICRYL* Plus Suture Compared to Chinese Silk in Scheduled Breast Cancer Surgery
This is a 90-day study to evaluate cosmetic outcome and Surgical Site Infection in approximately 100 patients from 6 centers in China undergoing scheduled modified radical mastectomy for breast cancer.
- Trial name
- NCT00768222
- Testing
- silk suture, VICRYL* Plus suture
- Where
- 6 sites in China
- Volunteers
- 101 people
- Sponsor
- Ethicon, Inc.
Obesity
Endoscopic Suturing System for Tissue Apposition
The objective of this feasibility trial is to evaluate the Ethicon Endo-Surgery Endoscopic Suturing System (ESS) for tissue apposition and reduction of the size of a dilated GJ anastomosis in subjects who are regaining weight…
- Trial name
- NCT00495222
- Testing
- Tissue plication, Endoscopic Suturing System
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Ethicon Endo-Surgery
Treatment of Obesity
A Post-Market Surveillance Study of Using the g-Cath EZ for Treating Obesity
This is a multi-center, prospective study evaluating a treatment for obesity.
- Trial name
- NCT03721731
- Testing
- Obesity treatment with a Plication device
- Where
- 2 sites in Spain
- Volunteers
- 39 people
- Sponsor
- USGI Medical
Pediatric and Adult: Mucosal Closure in Facial and Oral Surgery, Pediatric and Adult: Skin Closure (Dermal Sutures)
Prospective, International Monosyn® Quick - Non Interventional Study
The Monosyn® Quick non-interventional study (NIS) has been designed to implement an action within the framework of a proactive post-market surveillance system.
- Conditions
- Pediatric and Adult: Mucosal Closure in Facial and Oral Surgery, Pediatric and Adult: Skin Closure (Dermal Sutures), Women: Episiotomy, Pediatric: Urological Interventions (Circumcision, Phimosis Etc.)
- Trial name
- PRIMOQ (NCT03355001)
- Testing
- Monosyn® Quick
- Where
- 3 sites in Germany
- Volunteers
- 153 people
- Sponsor
- Aesculap AG
Hemorrhoids, Hemorrhoids, Internal
SCI-Pex Study - Safety and Performance of PexyEazy®, a Device for Treatment of Hemorrhoids
The SCI-Pex study is a multicenter, prospective, non-controlled investigation on PexyEazy®, a new device for treatment of hemorrhoids based on the mucopexy method.
- Conditions
- Hemorrhoids, Hemorrhoids, Internal, Suture; Complications, Infection or Inflammation, Rectal Diseases
- Trial name
- SCI-Pex (NCT05782010)
- Testing
- PexyEazy
- Where
- 3 sites in Sweden
- Volunteers
- 35 people
- Sponsor
- Developeration AB
C.Surgical Procedure; Digestive System, Symptomatic Disorders of the Gastrointestinal Tract
An International, Multicentric, Prospective, Observational Study to Evaluate Monosyn® Suture Material for Anastomoses in the Gastrointestinal Tract
The aim of this non-interventional study is to evaluate the efficacy of a monofilament, mid-term absorbable suture material (Monosyn®) for anastomosis performed in the gastrointestinal tract using the frequency of anastomosis…
- Conditions
- C.Surgical Procedure; Digestive System, Symptomatic Disorders of the Gastrointestinal Tract, Gastric Anastomosis (Site), Gastrointestinal Neoplasms
- Trial name
- PROMEGAT (NCT02080702)
- Testing
- Monosyn
- Where
- 5 sites in Malaysia, Philippines and 2 more
- Volunteers
- 106 people
- Sponsor
- Aesculap AG
Weight Loss
OverStitch NXT Endoscopic Suture System
To demonstrate the safety and efficacy of OverStitch NXT Endoscopic Suture System for endoscopic sleeve gastroplasty（ESG） in obese populations to support the registration of OverStitch NXT for ESG indication.
- Trial name
- NCT07276815
- Testing
- OverStitch NXT Endoscopic Suture System
- Where
- China
- Volunteers
- 136 people
- Sponsor
- Boston Scientific Corporation
Peripheral Vascular Diseases, Hemostasis
Trial to Evaluate the Hemostatic Effect of Lyostypt® Versus Surgicel® in Arterial Bypass Anastomosis
The purpose of this trial is to demonstrate that the bleeding time of suture holes after construction of arterial bypass anastomosis is shorter after treatment with Lyostypt® than with Surgicel®
- Trial name
- COBBANA (NCT00837954)
- Testing
- Lyostypt® AND Surgicel®, Lyostypt®, Surgicel®
- Where
- Germany
- Volunteers
- 32 people
- Sponsor
- Aesculap AG
Sternotomy
Study Comparing Steel Wire to a Flat, Braided Suture to Close the Breastbone
This pilot study is prospective, randomized, single-blinded, single-center for adult patients undergoing sternotomy closure after cardiac surgery.
- Trial name
- NCT04743895
- Testing
- Stainless Steel Wire Cerclage
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Arthrex, Inc.
Wound Closure
Symmetric on Total Knee Arthroplasty (TKA)
A post-marketing prospective, multicenter, randomized controlled study to evaluate the wound closure efficiency of STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device (STRATAFIX Symmetric PDS Plus) compared to…
- Trial name
- SFX (NCT03305887)
- Testing
- "STRATAFIX™ Symmetric" Knotless Tissue, VICRYL® PLUS, "STRATAFIX Spiral" sutures
- Where
- 7 sites in China
- Volunteers
- 184 people
- Sponsor
- Johnson & Johnson Medical, China